Interstitial CystitisNCT01280864
MAPP Investigation of Pelvic Floor-Brain Neurobiologic Axis in IC/IBS and IBS
An observational study of Interstitial Cystitis and Irritable Bowel Syndrome, run by Augusta University at 1 site in United States.
Trial summary
Hypotheses: 1. The bidirectional signaling between the cortex, and the pelvic floor/gut is deranged in patients with IC and in IBS. Consequently, they will demonstrate hyperexcitability of the pelvic floor/brain axis as evidenced by shorter latencies and increased amplitudes for both the afferent anorectal-cortical… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Interstitial Cystitis, Irritable Bowel Syndrome
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2010to Aug 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Subjects: Sixty six consecutive adult, out-patients, over 18 years with IC alone and 66 adult patients with IBS alone and 30 healthy controls will be recruited for this 5 year study and to fulfill all 4 aims of this study. All study aims will recruit under a unified strategy. For most of the funding cycle, we will recruit simultaneously for several study aims. To prevent confusion about concordant studies, similar standardized forms and diagnostic tests will be used for each aim, with supplemental tools as needed.
Who may be able to join
- During the previous year, all patients must have recurrent abdominal discomfort or pain for at least 3 days per month in the last 3 months associated with two or more of the following symptoms (6): i) improvement with defecation; ii) onset associated with a change in frequency of stool; and/or iii) onset associated with a change in form (appearance) of stool (83);
- No evidence for structural diseases (excluded by colonoscopy/ barium enema and metabolic problem by lab tests; and
- On a prospective symptom/stool diary [Appendix 1] patients reported i) presence of abdominal pain/discomfort for at least 2 days per week; ii) hard or lumpy stools >25% and loose or watery stools in < 25% of bowel movements (IBS-C); (iii) loose or watery stools in >25% of bowel movements and hard stools <25% of BMs(IBS-D); >25% of hard or loose stools within one week (IBS-M) (6).
- IC/PBS patients who have met all three of the modified NIDDK criteria (84) for IC/PBS as described below on a urinary symptom assessment form (Appendix 3):
- Participants will report the occurrence of bladder pain with a score of >3 on a Likert scale of 1-10.
- Participants will report the presence of increased urinary frequency with a score of >3 on a Likert scale of 1 -10.
- The bladder pain and increased urinary frequency will have been present for at least 6 weeks.
- We recognize that the NIDDK is currently working on recommending new diagnostic criteria for interstitial cystitis. We will adopt any revised criteria commiserate with the new recommendations of the NIDDK as our study progresses.
Who cannot join
- Patients with laxative abuse, anorexia nervosa, and bulimia;
- Patients taking constipating drugs, (e.g. opioids), tricyclics (because of increased seizure risk), serotonin modulators (tegaserod), antispasmodics (dicyclomine or hyoscyamine), muscle relaxants (e.g. cyclobenzaprine) unless the drug is stopped at least 2 weeks before enrollment;
- Patients with a current history of depression and/or taking antidepressants;
- Patients with comorbid illnesses, severe cardiac disease, chronic renal failure or previous gastrointestinal surgery except cholecystectomy and appendectomy;
- Patients with neurologic diseases (e.g. head injuries, epilepsy, multiple sclerosis, strokes, spinal cord injuries) or brain disorders prone to causing seizures;
- Patients experiencing impaired cognizance (mini mental score of < 15) and/or legally blind;
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- Women who are pregnant or likely to conceive (women with potential for pregnancy must use contraceptive measures to be included);
- Patients with ulcerative and Crohns colitis;
- Patients with rectal prolapse, anal fissure, anal surgery or inflamed hemorrhoids.
- Interstitial Cystitis/Painful Bladder Syndrome (IC/PBS) Study Population
- History of genitourinary tuberculosis, bladder cancer, high grade dysplasia, carcinoma in situ, urethra, vaginal, or cervical cancer.
- Previous treatment with cytoxan or cyclophosphamide (as reported by the patient).
- Radiation cystitis (as reported by the patient).
- Neurogenic bladder dysfunction (e.g.,) due to spinal cord injury, stroke, Parkinson's, MS, spina bifida, or diabetic cystopathy (reported by the patient or determined during a neurologic exam.
- Having had an augmentation cystoplasty (as reported by the patient).
- Having undergone a cystectomy, cystolysis, or neuroectomy as reported by the patient.
- Having a urethral stricture of less than 12 French (as reported by the patient).
- Urinalysis with >10 white blood cells per high-powered field.
- A positive urine culture for bacterial cystitis within the past three months (by report) or a positive dipstick for leucocyte esterase or nitrates on urinary dipstick test at the time of presentation.
- Symptoms of vaginitis (as reported by the patient).
- Active herpes at presentation or has had active herpes in the last three months (by report).
- Use of antimicrobials in the past three months for urinary tract infections (by report).
- Presence of bladder, ureteral, or urethral calculi (as reported by the patient).
- Having undergone a cystometrogram, bladder cystoscopy under anesthesia or bladder biopsy under anesthesia or urethral dilation within the 6 weeks.
- Pregnancy.
- Additional Criteria for recruitment:
- Patients will be assessed no sooner than 6 weeks following a DMSO or other treatment or a hydrodistention as these treatments may influence inflammation. Subjects should have had no infectious illness within 2 weeks of participation. As estrogen levels are thought to contribute to IC symptoms, and symptom exacerbation has been reported perimenstrually (85), all menstruating subjects will be tested during the mid-luteal portions of their menstrual cycle (approx. days 7-14) to control for hormonal variability.
- We weighed the issue of excluding IC patients taking pain and psychotropic medication vs. including these patients. Amitriptyline is commonly used for treatment of pain in both IC and IBS; these patients commonly take other psychotropic drugs, systemic antihistamines, and drugs for pain. If we were to exclude all patients on any medication, we would be able to recruit a small and unrepresentative sample of the healthiest IC patients. If we asked patients to refrain from using medication for 2 weeks before the study, we would be subjecting them to undue pain and hardship, and might trigger an exacerbation of the disease. However, use of antihistamines affect measurements of methylhistamine, and use of amitriptyline and other anti- depressants produce a general blunting of the HPA response to a stressful stimuli (86, 87) as well as modulate the neurobiologic responses. We will exclude all subjects on antidepressants to examine a more homogeneous population. To try to obtain as representative a sample as possible without confounding of results we used the following strategy in our pilot studies and plan to use the same strategy in the proposed study. Subjects taking systemic antihistamines could not be included if they had taken antihistamines within a week of the study. Our preliminary data indicated that there was no significant difference in the ACTH or cortisol response to the reactivity challenge among patients using vs. those not using amitriptyline or other psychotropic medications (p's = .45 to .90).
- Healthy Controls study population:
- Additionally, we will recruit 30 healthy controls matched for our patient group with regards to age, gender, hormonal status and parity. Controls will be healthy women with no history of urological disease or genito-urinary symptoms and no immunomodulatory disease such as rheumatoid arthritis, lupus, MS, chronic fatigue, fibromyalgia, diabetes, cancer, HIV, vestibulitis, allergies, chronic fungal infections, migraines, depression, or chronic pain conditions. Healthy controls will be asked to complete the Mayo Health Screening survey and this will be used to adjudicate their health status.
- Healthy controls will be on NO meds other than multivitamins, oral contraceptives, and possibly low dose aspirin. They can not be taking anti-hypertensives, serotonin reuptake inhibitors, thyroid meds or other medications.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52246
About this study
Official title: Investigation of Pelvic Floor-Brain Neurobiologic Axis in IC/IBS and IBS
Hypotheses:
- The bidirectional signaling between the cortex, and the pelvic floor/gut is deranged in patients with IC and in IBS. Consequently, they will demonstrate hyperexcitability of the pelvic floor/brain axis as evidenced by shorter latencies and increased amplitudes for both the afferent anorectal-cortical evoked potentials and efferent cortically-induced (magnetic) anorectal motor evoked potentials.
- Unlike patients with IC alone, patients with IBS will also demonstrate anorectal visceral hypersensitivity and anorectal sensory-motor dysfunction.
- Conditions
- Interstitial Cystitis, Irritable Bowel Syndrome
- Medical subject headings
- Cystitis, Interstitial, Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Interstitial Cystitis Alone | Not described | |
| Irritable Bowel Syndrome Alone | Not described | |
| Healthy Controls | Not described |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2011 (estimated)
- Study startMar 2010
- Primary completionAug 2011
- Study completionAug 2011
Why it stopped: the study PI left the university of iowa
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Interstitial CystitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Augusta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Satish Rao, Augusta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01280864
- Sponsor's protocol ID
- 200806750
- Status last verified
- Jul 2018
- First submitted
- 19 Jan 2011
- Last updated
- 23 Jul 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Pelvic Floor-Brain Neurobiologic Axis in IC/IBS and IBS
- ClinicalTrials.gov ID
- NCT01280864
- Acronym / sponsor ID
- 200806750
- Conditions
- Interstitial Cystitis, Irritable Bowel Syndrome
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: the study PI left the university of iowa
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Augusta UniversityUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 21 Jan 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Hypotheses:
- The bidirectional signaling between the cortex, and the pelvic floor/gut is deranged in patients with IC and in IBS. Consequently, they will demonstrate hyperexcitability of the pelvic floor/brain axis as evidenced by shorter latencies and increased amplitudes for both the afferent anorectal-cortical evoked potentials and efferent cortically-induced (magnetic) anorectal motor evoked potentials.
- Unlike patients with IC alone, patients with IBS will also demonstrate anorectal visceral hypersensitivity and anorectal sensory-motor dysfunction.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Interstitial Cystitis Alone | – | – |
| Irritable Bowel Syndrome Alone | – | – |
| Healthy Controls | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects: Sixty six consecutive adult, out-patients, over 18 years with IC alone and 66 adult patients with IBS alone and 30 healthy controls will be recruited for this 5 year study and to fulfill all 4 aims of this study. All study aims will recruit under a unified strategy. For most of the funding cycle, we will recruit simultaneously for several study aims. To prevent confusion about concordant studies, similar standardized forms and diagnostic tests will be used for each aim, with supplemental tools as needed.
Key inclusion criteria (8 listed)
- During the previous year, all patients must have recurrent abdominal discomfort or pain for at least 3 days per month in the last 3 months associated with two or more of the following symptoms (6): i) improvement with defecation; ii) onset associated with a change in frequency of stool; and/or iii) onset associated with a change in form (appearance) of stool (83);
- No evidence for structural diseases (excluded by colonoscopy/ barium enema and metabolic problem by lab tests; and
- On a prospective symptom/stool diary [Appendix 1] patients reported i) presence of abdominal pain/discomfort for at least 2 days per week; ii) hard or lumpy stools >25% and loose or watery stools in < 25% of bowel movements (IBS-C); (iii) loose or watery stools in >25% of bowel movements and hard stools <25% of BMs(IBS-D); >25% of hard or loose stools within one week (IBS-M) (6).
- IC/PBS patients who have met all three of the modified NIDDK criteria (84) for IC/PBS as described below on a urinary symptom assessment form (Appendix 3):
- Participants will report the occurrence of bladder pain with a score of >3 on a Likert scale of 1-10.
Key exclusion criteria (31 listed)
- Patients with laxative abuse, anorexia nervosa, and bulimia;
- Patients taking constipating drugs, (e.g. opioids), tricyclics (because of increased seizure risk), serotonin modulators (tegaserod), antispasmodics (dicyclomine or hyoscyamine), muscle relaxants (e.g. cyclobenzaprine) unless the drug is stopped at least 2 weeks before enrollment;
- Patients with a current history of depression and/or taking antidepressants;
- Patients with comorbid illnesses, severe cardiac disease, chronic renal failure or previous gastrointestinal surgery except cholecystectomy and appendectomy;
- Patients with neurologic diseases (e.g. head injuries, epilepsy, multiple sclerosis, strokes, spinal cord injuries) or brain disorders prone to causing seizures;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early (reason given: the study PI left the university of iowa). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Interstitial Cystitis and Irritable Bowel Syndrome, run by Augusta University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 23 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: the study PI left the university of iowa). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2018.